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Questions & answers

This page provides Questions & Answers about the IVDR with relevance for diagnostic laboratories/health institutions.

Questions can be submitted to This Q&A page is work in progress and will be updated throughout the final year before the date of application; we will do our best to take along all the questions that we receive.

The information on this page was composed using our best knowledge, based on the currently available sources. Note that the implementation of the IVDR is an ongoing process and new information will become available continuously in the coming period. If you notice that any information can be updated, you are welcome to let us know.

What is the IVDR?
What are in vitro diagnostic medical devices (IVDs)?
Why was a new regulation on IVDs needed?
What are the consequences of the IVDR for diagnostic laboratories?
What are the consequences of the IVDR for IVD manufacturers?
What is written in the IVDR?